NCT07226869 Computer Guided Microwave Liver Ablation
| NCT ID | NCT07226869 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NE Scientific INC |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2030-02-28 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2026-05-08 with a primary completion date of 2030-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if the intraoperative use of a computer guidance software can improve the success of liver tumor ablation in adults. The employed software calculates and displays a simulation of the ablation such that the physician can visualize what portion of the target tumor has, and has not been treated at any point during the procedure. The main questions it aims to answer are: 1) Does the use of the computer guidance software reduce the number of times a tumor is incompletely treated. 2) Does the use of the computer guidance software reduce the rate of local tumor recurrence at 2 year follow-up? 3) Was there an increase or a decrease in medical problems for participants after a procedure where the guidance software was used? Researchers will compare liver tumor treatment using the computer guidance software with an historic control to see if the addition of the guidance software improved the outcomes after an ablation. Participants will: Undergo CT-guided microwave ablation treatment of a liver tumor using computer-assisted simulation. Visit the clinic at one month and then every 3 months for blood tests and a contrast-enhanced CT or MRI imaging study (as per standard of care)
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years, with life expectancy of at least 1 year 2. Diagnosis of hepatocellular carcinoma (HCC) confirmed by: * LI-RADS 5 imaging features or * Histopathology * Cirrhosis with AFP \> 400 3. Localized disease without macrovascular invasion or extrahepatic metastasis, eligible for curative-intent percutaneous thermal ablation, defined as: o Up to 5 lesions with at least one lesion, 2 -5 cm, and no lesion \>5 cm diameter 4. Tumor location deemed technically feasible for percutaneous ablation by the treating interventional radiologist 5. ECOG Performance Status 0-2 6. Adequate coagulation status, defined as: * Platelets ≥ 50,000/μL * INR ≤ 1.8 (or correctable) 7. Ability to undergo contrast-enhanced CT or MRI 8. Willingness and ability to provide informed consent Exclusion Criteria: 1. Prior local therapy to the target lesion (ablation, TACE, SBRT, or resection) or to a lesion within 1 cm of the target lesion 2. More than 5 hepatic lesions, or any lesion ineligible for technically complete ablation 3. uncontrolled hepatic decompensation, including: o Persistent encephalopathy 4. Uncorrectable coagulopathy or contraindication to percutaneous liver intervention 5. Contraindication to contrast-enhanced imaging (e.g., severe CKD without dialysis, contrast allergy not correctable with premedication) 6. Active systemic infection 7. Pregnancy 8. Inability to comply with follow-up imaging schedule
Contact & Investigator
Andrea Borsic, PHD
STUDY DIRECTOR
NE Scientific INC
Frequently Asked Questions
Who can join the NCT07226869 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07226869 currently recruiting?
Yes, NCT07226869 is actively recruiting participants. Contact the research team at hoffer@hitchcock.org for enrollment information.
Where is the NCT07226869 trial being conducted?
This trial is being conducted at Boston, United States, Lebanon, United States.
Who is sponsoring the NCT07226869 clinical trial?
NCT07226869 is sponsored by NE Scientific INC. The principal investigator is Andrea Borsic, PHD at NE Scientific INC. The trial plans to enroll 84 participants.
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